Fluid regulating device with torsional control

ABSTRACT

An improved fluid regulating device is used in a parenteral administration system having tubing. The device provides torsional flexure of the tubing by relative rotation between first and second body members to regulate fluid flow.

BACKGROUND OF THE INVENTION

This invention relates to parenteral administrations systems and fluidregulating devices, and most particularly, to an improved fluidregulating device for use in a parenteral administration system.

Parentral administration systems are utilized to transfer intravenoussolutions to medical patients. Such systems typically include a fluidsupply container, a parentral needle and tubing interconnecting thefluid supply container with the needle. Transfer of the solution isachieved through gravity by suspension of the container above thepatient.

A significant problem in the utilization of parentral administrationsystems is the regulation of the flow of solution to the patient. Thisproblem has along been known, and has resulted in a variety of fluidregulating devices. As an example, roller clamps have been attached tovariably compress the tubing and thereby provide a variable rate offlow. Generally, these devices all control fluid flow in the manner ofroller clamps, i.e., by pinching force on the tubing. While a few ofthese devices have proved highly useful, most are cumbersome,inaccurate, incapable of rapid variation or hazardous. No one devicefully satisfies long-felt needs for such devices.

A principal reason for the inadequacies of these devices is that thepinching of typical tubing results in deformation without reduction ofthe cross-sectional area of the internal passageway, until the tubing isalmost totally collapsed. As a result, fluid flow varies fromsubstantially full flow to zero flow over a minute range of deformationnear total tubing collapse. Truly accurate control of deformation inthis range is extremely difficult. Another reason for the inadequaciesof prior art devices is that typical tubing is not satisfactorilyresilient when pinched. As a result, accurate variation of fluid flowthrough the tubing from a pre-selected flow to a desired flow is alsodifficult, if not impossible.

SUMMARY OF THE INVENTION

It is thus an object of the present invention to provide an improvedfluid regulating device.

Another object of the present invention is to provide an improved fluidregulating device for use in a parenteral administration system having afluid supply container, a parenteral needle and tubing.

Another object of the present invention is to provide an improved fluidregulating device for use in a parenteral administration system whichprovides accurate and reproducable fluid flow rates.

Another object of the present invention is to provide an improved fluidregulating device for use in a parenteral administration system whichco-operates with the tubing typically utilized in parenteraladministration systems.

Another object of the present invention is to provide an improved fluidregulating device for use in a parenteral administration system which,in at least one embodiment, does not interrupt the tubing or otherwisecompromise the internal sterility thereof.

Another object of the present invention is to provide an improved fluidregulating device for use in a parenteral administration system that isstreamlined and economical of manufacture.

Thus, in a principal aspect, the present invention is an improved fluidregulating device for use in a parentral administration system having afluid supply container, a parentral needle and torsionally flexibletubing. The device comprises a first body member, first securing means,a second body member, second securing means, and mounting means. Thefirst body member has a first channel wall and a first chamber wall. Thefirst channel well defines a first channel for a first tubing portion offlexible tubing and the first chamber wall defines a first open-endedportion of a chamber along the first channel. The first chamber wall hasa minimum diametric dimension greater than the maximum outer dimensionof the flexible tubing. The first securing means is on the first bodymember for securing the first body member to the first tubing portionfor common rotation about a first axis through the chamber.

The second body member has a second channel wall and a second chamberwall. The second channel wall defines a second channel for a secondtubing portion of flexible tubing, and the second chamber wall defines asecond openended portion of the chamber along the second channel. Thesecond chamber wall has a minimum diametric dimension greater than themaximum outer dimension of the flexible tubing. The second securingmeans is on the second body member for securing the second body memberto the second tubular portion of flexible tubing for common rotationabout a second axis through the chamber.

The mounting means is on the first body member and the second bodymember. The mounting means mounts the first body member to the secondbody member with the axes coincident and the first portion of thechamber open to the second portion of the chamber. The mounting meansprovides for relative rotation of the body members about the axes. Withthe two body members thus mounted, an unsecured portion of flexibletubing that is intermediate and joined to the first and second tubingportions passes through the chamber.

The first body member is rotatable relative to the second body memberbetween a first relative rotational position and a second relativerotational position. In the first relative rotational position, theunsecured tubing portion is in a first condition of torsional flexure.In the second relative rotational position, the unsecured tubing portionis in a second condition of torsional flexure. Thus, the flexible tubingis torsionally flexed by relative rotation of the first and second bodymembers so as to regulate the fluid flow therethrough.

As should now be understood, the improved fluid regulating device of thepresent invention co-operates with and may have as an element thereoftorsionally flexible tubing. It has been discovered through thisinvention that the tubing typically used in parenteral administrationsystems is torsionally flexible, such that torsional flexure of thetubing provides significantly improved characteristics of fluid flowvariation. Flow varies in the tubing substantially uniformly over abroad range of torsional flexure, and the tubing is significantly moreresilient to torsional flexure than pinching. Thus, it is believed thatthe present invention is a significant advance in the art of fluidregulating devices, specifically those for parenteral administrationsystems. For a more thorough understanding of the present invention,attention is directed to the four preferred embodiments disclosedherein.

BRIEF DESCRIPTION OF THE DRAWINGS

In the detailed description which follows, four preferred embodiments ofthe present invention are described in relation to the accompanyingdrawing, which consists of fifteen figures. The first preferredembodiment is illustrated in FIGS. 1-7, the second in FIGS. 8-12, thethird in FIGS. 13-14, and the fourth in FIG. 15. These fifteen figuresare briefly described as follows:

FIG. 1 is an elevational view of a complete parenteral administrationsystem incorporating the first preferred embodiment of the presentinvention;

FIG. 2 is an elevational view of the first preferred embodiment of thepresent invention in situ;

FIG. 3 is a cross-sectional view of the tubing of the parenteraladministration system of FIG. 1, taken along line 3--3 of FIG. 2;

FIG. 4 is a top plan view of the first preferred embodiment of thepresent invention, taken along line 4--4 of FIG. 2;

FIG. 5 is a cross-sectional view of the first preferred embodiment insitu, with the tubing fully open for maximum infusion rate, taken alongline 5--5 of FIG. 4;

FIG. 6 is a bottom plan view of the first preferred embodiment of thepresent invention, taken along line 6--6 of FIG. 2;

FIG. 7 is a cross-sectional view of the first preferred embodiment insitu, with the tubing torsionally adjusted for a reduced infusion rate,taken along line 7--7 of FIG. 4;

FIG. 8 is an elevational view of the second preferred embodiment of thepresent invention in situ;

FIG. 9 is a top plan view of the second preferred embodiment of thepresent invention, taken along line 9--9 of FIG. 8;

FIG. 10 is a cross-sectional view of the second preferred embodiment ofthe present invention, similar to FIG. 5, taken along line 10--10 ofFIG. 9;

FIG. 11 is a bottom plan view of the second preferred embodiment of thepresent invention, taken along line 11--11 of FIG. 8;

FIG. 12 is a cross-sectional view of the second preferred embodiment ofthe present invention similar to FIG. 7, taken along line 12--12 of FIG.9;

FIG. 13 is a cross-sectional view of the third preferred embodiment ofthe present invention, similar to FIGS. 6 and 11;

FIG. 14 is a cross-sectional view of the third preferred embodiment ofthe present invention, similar to FIGS. 7 and 12; and

FIG. 15 is a cross-sectional view of the fourth preferred embodiment ofthe present invention, similar to FIGS. 5, 10 and 13.

In the drawing and the detailed description of the four preferredembodiments which follows, like reference numerals refer to likecomponents of the four embodiments.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIG. 1 of the accompanying drawing, the first preferredembodiment of the present invention is a fluid regulating device 20 foruse in a parenteral administration system having a fluid supplycontainer 22, a parenteral needle 24 and flexible tubing 26. The device20 in situ is positioned along the flexible tubing 26 intermediate orbetween the fluid supply container 22 and the needle 24. In use, thesupply container 22, which may be a bottle or bag or the like, issuspended from a fixture such as a hook 28, which is shown supported bya stand having a base 30 and a supporting column 32. The container 22contains a fluid parenteral solution 34 intended for a medical patient(not shown). The container 22 feeds the solution 34 by gravity to aconventional drip chamber 36 and into the flexible tubing 26. Thesolution 34 passes through the flexible tubing 26, including anextensible and retractable coil 38 thereof, to the needle 24. The needle24 is introduced into the body of the patient as by insertion into avein, and the solution 34 is thereby administered to the patient. Itshould be understood that this parenteral administration system isdescribed for environmental purposes only, and that the second, thirdand fourth preferred embodiments of the present invention are utilizedas is the first.

Referring to FIG. 2, the device 20 includes a first body member 40 and asecond body member 42. While orientation of the device 20 does notaffect its operation, the first body member 40 is shown in FIG. 2mounted atop the second body member 42. The body members 40, 42 arealigned along a vertical axis 44 about a horizontal midline 46. Thisorientation is typical when the device 20 is in position for usage.

Each body member 40, 42 includes an indicator portion 48, a handleportion 50 and a tube receiving portion 52. The indicator portions 48are adjacent the midline 46. The handle portions 50 are adjacent theindicator portions 48, opposite each other about the midline 46. Thetube receiving portions 52 are also opposite each other about themidline 46, and adjacent the handle portions 50. As shown in FIGS. 4 and6, portions 48, 52 are generally cylindrical about the axis 44, whilethe handle portions 50 include axially extending ribs 54 about theircircumferences. The portions 52 have a diameter greater than butsubstantially comparable to the mean diameter of the tubing 26, theportions 50 have a minimum diametric dimension greater than the diameterof the portions 52 and the portions 48 have a diameter greater than themaximum diametric dimension of the portions 50. As most preferred, thebody members 40, 42 are molded of plastic.

Referring to FIG. 5, the first body member 40 defines a first channel 56for tubing 26, the second body member 42 defines a second channel 58 fortubing 26 and the body member 40, 42 together define a chamber 60. Thechannels 56, 58 and the chambers 60 are generally cylindrical andaligned along the axis 44. The first channel 56 is defined by a firstchannel wall 62 of the first body member 40. The second channel 58 isdefined by a second channel wall 64 of the second body member 42. Thechamber 60 is defined by a first chamber wall 66 of the first bodymember 40 and a second chamber wall 68 of the second body member 42. Thechamber 60 is intermediate the first channel 56 and the second channel58, with the first chamber wall 66 defining the upper portion of thechamber 60 and the second chamber wall 68 defining the lower portionthereof.

The first body member 40 is mounted atop the second body member 42 forrelative rotation therebetween about the axis 44. The second chamberwall 68 defines an upstanding, internal flange 70 within the indicatorportion 48 of the second body member 42. An upstanding, external flange72 extends about the periphery of the indicator portion 48 of the secondbody member 42. The flanges 70, 72 are cylindrical and define an annularrecess 74 between the flanges 70, 72. A mating flange 76 extendsdownward from the indicator portion 48 of the first body member 40 intothe recess 74. Relative rotation of the body members 40, 42 occurs byrotational sliding movement of the mating flange 76 in the recess 74. Aretainer ring 78 extends through a first groove 79 in the indicatorportion 48 of the first body member 40 into a second groove 80 in theinternal flange 70. The retainer ring 78 retains the mating flange 76 inthe recess 74 and prevents axial movement between the body members 40,42.

The first body member 40 is secured to the tubing 26 along the firstchannel 56, and the second body member 42 is secured to the tubing 26along the second channel 58. As shown best in FIG. 3, the tubing 26 hasa plurality of radially outwardly extending ribs or fins 82 in at leastthe area of the device 20. Referring to FIGS. 4 and 6, the first andsecond channel walls 62, 64 include axially extending, radially inwardlyextending mating ribs 84 that mate with the ribs 82. The ribs 82, 84mate loosely such that the device 20 is axially moveable relative to thetubing 26 while the body members 40, 42 are secured for common rotationabout the axis 44 with the flexible tubing 26. That is, the device 20 isslidable along the tubing 26, while rotation of the body member 40, 42causes rotation of adjacent portions of the tubing 26. Specifically, andwith reference to FIG. 7, rotation of the fist body member 40 causesrotation of a first tubing portion 86 of the tubing 26 defined along thefirst channel 56; rotation of the second body member 42 causes rotationof a second tubing portion 88 of the tubing 26 defined along the secondchannel 58.

As should now be apparent, relative rotation between the body members40, 42 causes relative rotation between the tubing portions 86, 88.Because the tubing portions 86, 88 are joined to each other by a tubingportion 90 within the chamber 60, and because the tubing portion 90 isunsecured, relative rotation between the tubing portions 86, 88 resultsin torsional flexure or twisting of the unsecured tubing portion 90, asshown in FIG. 7.

The torsional flexure of the unsecured tubing portion 90 constricts theinternal passageway in the tubing portion 90, thereby resulting inreduced fluid flow through the tubing 26. Increased and decreasedtorsional flexure of the unsecured tubing portion 90 results inincreased and decreased fluid flow therethrough, respectively. Thus,fluid flow is dependent on torsional flexure and the relative rotationbetween the body members 40, 42. Calibration of the relative rotation ofthe body members 40, 42 provides for the selection of fluid flow by theselection of a relative rotational position.

Maintenance of the relative rotational position of the body members 40,42 causes a constant flow through the device 20. As shown in FIGS. 5 and6, the first body member 40 includes a detent 92 along the bottom of theflange 76. The detent 92 has a hemispherical shape and cooperates withdetent openings 94 in the second body member 42. The detent openings 94are best seen in FIG. 6, where only one detent opening is referenced,for clarity. The detent openings 94 are defined in the recess 74 of thesecond body member 42. As formed of plastic, the body members 40, 42 areflexible to provide for movement of the detent 92 from detent opening 94to detent opening 94. If the body members 40, 42 are formed ofnon-flexible material, the detent 92 is made spherical and biased towardthe detent openings 94 by a spring set within a recess in the flange 76.

Placement of the detent openings 94 determines the calibration of thebody member 40, 42. Movement of the detent 92 from one detent opening 94to an adjacent detent opening 94 causes an incremental change in fluidflow rate. As shown in FIG. 2, the position of the detent 92 isindicated on the indicator portions 48 by a marker 96 and markings 98.

Referring now to FIGS. 8-11, the second preferred embodiment of thepresent invention is a device 100. As shown and indicated by likereference numerals, the device 100 is substantially similar to thedevice 20. Significant differences include the provision of a captivetubing segment 102 and tapered tips 104 on the tube receiving portions52. The captive tubing segment 102 and the tips 104 permit the placementof the device 100 in a length of smooth-wall tubing 26 that has beenpreviously connected with a needle 24 and container 22. The tubing 26 iscut between the container 22 and the needle 24 to provide free ends 106,108. The end 106 is placed over the tip 104 of the first body member 40and the end 108 is placed over the tip 104 of the second body member 42.The ends 106, 108 are clamped or glued in position, or as shown in FIG.8, held in position under the tension of diametric expansion. Thechannels 110, 112 of the device 100 have a diameter along the tips 104substantially equal to the normal inner diameter of the tubing 26.Adjacent the chamber 60, the channels 110, 112 are enlarged toaccomodate the captive tubing segment 102. The segment 102 is captive inthe sense that assemblage of the device 100 involves the non-removableplacement of the segment 102 within the enlarged portions of thechannels 110, 112 and the chamber 60. The first tubing portion 86, thesecond tubing portion 88 and the unsecured tubing portion 90 are definedwithin the captive tubing segment 102. Thus, the device 100 providesfluid flow regulation substantially like the device 20, as shown inFIGS. 10 and 12.

Referring to FIGS. 13-14, the third preferred embodiment of the presentinvention is a device 120. In the device 120, the tubing 26 and channels122, 124 have smooth cylindrical surfaces or walls. Common rotation ofthe tubing portions 86, 88 with the body member 40, 42 and thus,torsional flexion of the tubing 26, is provided by loosely coiledhelical springs 126. The springs 126 are positioned within the chamber60 about the tubing 26 with ends 128 embedded within the body members40, 42. Relative rotation of the body member 40, 42 causes torsionalflexure of the springs 126, which by friction against the tubing 26causes torsional flexure thereof.

Referring to FIG. 15, the fourth preferred embodiment of the presentinvention is a device 140. The channels 142, 144 are enlarged toaccomodate a tubing segment 146 separate from the tubing 26. The tubingsegment 144 has an inner diameter greater than the outer diameter of thetubing 26, and the tubing 26, tubing segment 146 and channels 142, 144have smooth cylindrical surfaces. The first tubing portion 86, thesecond tubing portion 88 and the unsecured tubing portion 90 are definedwithin the tubing segment 146. The tubing 26 is inserted through thetubing segment 146. The first body member 40 is secured to the firsttubing portion 86 by chemically reactive glue or the like, and thesecond body member 42 is similarly secured to the second tubing portion88. Rotation of the body members 40, 42 causes torsional flexure of thetubing segment 146 and thereby the flexible tubing 26.

Each of the four preferred embodiments of the present invention hassignificant advantages. The first embodiment is movable along the ribbedportion of the tubing 26 to any desired position and need not besterile, since the interior of the tubing 26 does not contact any partof the device 20. The second preferred embodiment can be spliced into apreviously assembled parenteral administration system and no risk ofinaccurate fluid flow is caused by any possible abberation in thetorsional flexure characteristics of the tubing 26 previously chosen forthe system. Neither the third preferred embodiment nor the fourthpreferred embodiment need be sterile, and each is useful with standardsmoothwall intravenous tubing. Each is movable along the tubing like thefirst preferred embodiment, and each has the accuracy advantage of thesecond preferred embodiment. At present, the third preferred embodimentis most preferred, because of its extreme accuracy.

A highly important invention to the art of fluid regulating devices forparenteral administration systems has now been described. Toparticularly point out and distinctly claim the subject matter regardedas invention, the following claims conclude this specification. Exceptas set forth in the claims, or as corresponding to elements set forth inthe claims, the details of the four preferred embodiments of the presentinvention are illustrative and not restrictive. All devices, whichthough varied in detail, come within the proper scope of the claims areintended to be embraced therein.

What is claimed is:
 1. An improved fluid regulating device for use in aparenteral administration system having a fluid supply container, aparenteral needle and torsionally flexible tubing, comprising:a firstbody member having a first channel wall and a first channel wall, thefirst channel wall defining a first channel for a first tubing portionof flexible tubing and the first chamber wall defining a firstopen-ended portion of a chamber along the first channel, the firstchamber wall having a minimum diametric dimension greater than themaximum outer dimension of the flexible tubing; first securing means onthe first body member for securing the first body member to the firsttubing portion for common rotation about a first axis through thechamber; a second body member having a second channel wall and a secondchamber wall, the second channel wall defining a second channel for asecond tubing portion of the flexible tubing and the second chamber walldefining a second open-ended portion of the chamber along the secondchannel, the second chamber wall having a minimum diametric dimensiongreater than the maximum outer dimension of the flexible tubing; secondsecuring means on the first body member for securing the second bodymember to the second tubular portion for common rotation about a secondaxis through the chamber; mounting means on the first body member andthe second body member for mounting the first body member to the secondbody member with the axes coincident for rotation about the axes, andwith the first portion of the chamber open to the second portion of thechamber such that an unsecured portion of flexible tubing that isintermediate and jointed to the first tubing portion and the secondtubing portion passes through the chamber, and with the first bodymember being rotatable relative to the second body member such that in afirst relative rotational position, the unsecured tubing portion is in afirst condition of torsional flexure and in a second relative rotationalposition, the unsecured tubing portion is in a second condition oftorsional flexure; whereby the unsecured portion of the flexible tubingis torsionally flexed by relative rotation of the first and second bodymember so as to regulate fluid flow therethrough.
 2. An improved fluidregulating device for use with torsionally flexible tubing, comprising:afirst body member having a first channel wall and a first chamber wall,the first channel wall defining a first channel for a first tubingportion of flexible tubing and the first chamber wall definig a firstopen-ended portion of a chamber along the first channel, the firstchamber wall having a minimum diametric dimension greater than themaximum outer dimension of the flexible tubing; first securing means onthe first body member for securing the first body member to the firsttubing portion for common rotation about a first axis through thechamber; a second body member having a second channel wall and a secondchamber wall, the second channel wall defining a second channel for asecond tubing portion of the flexible tubing and the second chamber walldefining a second open-ended portion of the chamber along the secondchannel, the second chamber wall having a minimum diametric dimensiongreater than the maximum outer dimension of the flexible tubing; secondsecuring means on the first body member for securing the second bodymember to the second tubular portion for common rotation about a secondaxis through the chamber; mounting means on the first body member andthe second body member for mounting the first body member to the secondbody member with the axes coincident for rotation about the axes, andwith the first portion of the chamber open to the second portion of thechamber such that an unsecured portion of flexible tubing that isintermediate and jointed to the first tubing portion and the secondtubing portion passes through the chamber, and with the first bodymember being rotatable relative to the second body member such that in afirst relative rotational position, the unsecured tubing portion is in afirst condition of torsional flexure and in a second relative rotationalposition, the unsecured tubing portion is in a second condition oftorsional flexure; whereby the unsecured portion of the flexible tubingis torsionally flexed by relative rotation of the first and second bodymember so as to regulate fluid flow therethrough.
 3. An improved fluidregulating device as in claim 1 or 2 further comprising means on thefirst body member and the second body member in the second body memberfor releasably maintaining the first body member in the first and secondrotational positions.
 4. An improved fluid regulating device as in claim1 or 2 further comprising said flexible tubing including outwardlyextending ribs therealong, in which the first securing means and thesecond securing means include inwardly extending ribs formed along thefirst and second channel walls which mate with the outwardly extendingribs to provide for said common rotation.
 5. An improved fluidregulating device as in claim 4 wherein the inwardly extending ribs mateloosely with the outwardly extending ribs to provide for movement of thefluid regulating device along the flexible tubing.
 6. An improved fluidregulating device as in claim 1 or 2 in which the flexible tubingincludes physically separate first, second and third tubing segments,the first tubing portion, the second tubing portion and the unsecuredtubing portion being formed in the third segment of the tubing, in whichthe first body member includes a first fitting for attachment of thefirst tubing segment, and in which the second body member includes asecond fitting for attachment of the second tubing segment.
 7. Animproved fluid regulating device as in claim 6 in which the first andsecond fittings are tapered for insertion within the first and secondtubing segments, respectively.
 8. An improved fluid regulating device asin claim 1 or 2 in which the first tubing portion is attached to thefirst body member and the second tubing portion is attached to thesecond body member.
 9. An improved fluid regulating device as in claim 1or 2 in which the flexible tubing includes a first tubing segment havinga first outer diameter and a second tubing segment having an innerdiameter greater than the first outer diameter, the first, second andthird tubing portions being formed in the second segment of tubing, inwhich the first and second channel walls have minimum diametricdimensions greater than the outer diameter of the first segment oftubing, and in which the first and second chamber walls have a minimumdiametric dimension greater than the outer diameter of the second tubingsegment,whereby the first tubing segment is inserted through the secondtubing segment and flexure of the second tubing segment causes flexureof the first tubing segment.
 10. An improved fluid regulating device isin claim 1 or 2 further comprising a helical spring positioned generallywithin the chamber about the unsecured tubing portion and having endsattached to the first and second body members,whereby relative rotationof the first and second body members causes torsional flexure of thespring and thereby the unsecured tubing portion.